Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-04-03

Brief Summary

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This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.

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Detailed Description

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The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.

Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to controll group or lidocaine group. Participants of control group are given placebo while participants of lidocaine group are given lidocaine.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients, endoscopist, anesthetist, and data collection observers were all blinded to the group allocation.

Study Groups

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Group Placebo

the control group will be given the same volume of saline as the experimental group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

the control group will be given the same volume of saline.

Group Lidocaine

the experimental group will be given l-1.5mg lidocaine and then 2mg/kg/h

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h

Interventions

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Placebo

the control group will be given the same volume of saline.

Intervention Type DRUG

Lidocaine

the experimental group will be given 1.5mg/kg lidocaine and then 2mg/kg/h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 65-85 years old
* physical status ASA I, II, III,
* ERCP scheduled

Exclusion Criteria

* ASA IV or higher
* severe renal, cardiac or liver failure,
* allergy to lidocaine,
* patients weighing less than 40 kg,
* inability to give informed consent

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No